Pharmacokinetics of Topical SB204 in Adolescents With Acne Vulgaris
Completed · Phase 1
Conditions studied: Acne Vulgaris
In brief
A Phase 1, Single-center, Open-label, Pharmacokinetic, Safety and Tolerability Study of SB204 in Adolescents with Moderate to Severe Acne Vulgaris
Key facts
- Study ID
- NCT02801903
- Run by
- Novan, Inc.
- People needed
- 18
- Starts
- 2016-06-07
- Expected to finish
- 2016-08-25
- Last updated by the study team
- 2018-10-12
Who can join
Age: 9 and older, up to 16. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Otherwise healthy male and female adolescent subjects with moderate to severe acne vulgaris on a 5 point IGA scale
- At least 20 total inflammatory lesions (papules and pustules), and at least 20 total non-inflammatory lesions (open and closed comedones) on the face, chest, back, and shoulders
- Age 9-16 years, 11 months inclusive
- Subjects with methemoglobin level less than 3% at Screening and Baseline by pulse co-oximeter
You may not qualify if…
- Subjects with any other acne-like dermatological conditions such as severe, recalcitrant nodulocystic acne, acne conglobata, acne fulminans, acne secondary to medications or other medical conditions, perioral dermatitis, clinically significant rosacea, or gram-negative folliculitis;
- Any subject with skin disorders of an acute or chronic nature including psoriasis, eczema, tinea versicolor, etc.
- Subjects who reside in a dwelling that relies on well water for a primary drinking source
- Subjects with facial hair (beards, mustaches, etc.), tattoos or other facial markings that would interfere with assessments and study drug application
- Transgender subjects receiving hormone supplement (male to female or female to male)
- Subjects with a previous history of methemoglobinemia or taking medications known to be associated with methemoglobinemia
- Subjects with a known history of HIV, hepatitis, or other blood-borne pathogens
- Females who are pregnant, planning a pregnancy or breastfeeding
- Subjects previously treated with NVN1000 Gel / SB204
Where it is running
- WCCT #1 — Austin, Texas, United States
Full record on ClinicalTrials.gov
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